Abstract

Aim

Dermatological chemotherapy side effects, especially Hand and Foot Syndrome (HFS), are frequent in cancer patients receiving antitumor therapy, and have a negative impact on quality of life (QoL). Until now no medications have been established as standard therapy of HFS. The aim of this study was to investigate if the new antioxidant-containing topical formulation (elima®) is effective for HFS treatment in cancer patients from the physician's and patient's perspective.

Methods

59 cancer patients (colorectal, breast and renal cancer) receiving antitumor therapy including mainly capecitabine or target agents (sorafenib, sunitinib) with developed HFS, WHO grades I-III (without open wounds) were included in multicenter observational QoL study (mean age 62.4 ± 10; male/female–21/38). All the patients received HFS treatment using elima (n = 30) or moisturizing skin care agent containing vitamin F–SC-F (n = 29) twice a day. Physicians evaluated HFS treatment efficacy by changes in HFS severity grades. The patients filled out the Comprehensive Symptom Profile in Patients with HFS questionnaire (CSP-HFS) before and 9-10 weeks after HFS treatment start. Treatment groups were similar by gender, age and WHO grades. Statistical analysis was made using t-test and general liner model with adjustment for HFS grade and base line symptom severity.

Results

HFS improvement was more pronounced in patients on elima versus on SC-F: HFS severity according to WHO grades decreased in 77% patients vs 26% patients (p < 0.001). No patients worsened on elima; 7% had HFS worsening on SC-F. Severity of all symptoms according to the CSP-HFS decreased significantly on elima (ES=0.25–0.97) as compared with slight severity reduction of 9 symptoms (ES=0.2–0.73) and itching worsening on SC-F (p < 0.01). Total symptom severity reduction was more explicit on elima than on SC-F (?22.5 vs ?13.9, ES=0.38). HFS in patients with WHO grades III improved much better on elima than on SC-F: HFS severity according to WHO grades decreased in 68% vs 27% patients (p = 0.03).

Conclusions

The study shows that elima is an effective treatment for HFS from both physician's and patient's perspective and is superior to generally accepted treatment with SC-F.

Disclosure

T.P. Nikitina: The study was supported by Tirupharm LTD; K.A. Kurbatova: The study was supported by Tirupharm LTD; I. Bazin: The study was supported by Tirupharm LTD; A. Belonogov: The study was supported by Tirupharm LTD; G. Kolesnikov: The study was supported by Tirupharm LTD; M. Panina: The study was supported by Tirupharm LTD; P. Borisov: The study was supported by Tirupharm LTD; T.I. Ionova: The study was supported by Tirupharm LTD